StoryRegulatory
FDA grants De Novo authorisation for Distalmotion's Dexter in inguinal hernia repair
The FDA authorised Dexter for adult laparoscopic inguinal hernia repair, opening the US market to the Swiss robot. Distalmotion targets outpatient settings, where it says over 90% of US inguinal hernia repairs already happen. More than 1,300 patients had been treated with Dexter in Europe by then.
- De Novo marketing authorisation for adults aged 22 and older.
- Mobile, modular system designed for outpatient departments and ambulatory surgery centres.
- Open platform: works with third-party 3D imaging, energy devices and vessel sealers.
- Uses single-use, fully wristed instruments that need no reprocessing.